Posted 09 October 2014
By Alexander Gaffney, RAC
In one of the most unusual Warning Letters sent by the US Food and Drug Administration (FDA) this year, a dietary supplement manufacturer has been chided by regulators for allegedly failing to allow an inspector to fully inspect the facility, allegedly because the products manufactured there contained an active ingredient also contained in Pfizer's Viagra.
As recounted in FDA's 26 September 2014 Warning Letter, FDA inspectors arrived at Pennsylvania-based Nova Products' facility in January 2014 following reports that several of the products manufactured there contained "undeclared active pharmaceutical ingredients." Subsequent testing conducted by FDA confirmed the presence of the active ingredient sildenafil in four products made by the company, and the presence of both sildenafil and tadalafil in four other products.
Sildenafil is the active ingredient in Pfizer's Viagra, and tadalafil is the active ingredient in Eli Lilly's Cialis—both FDA-approved treatments for erectile dysfunction.
The eight products were all marketed as dietary supplements, FDA said. However, under federal law, supplements cannot contain active ingredients that are approved as drug products (except under rare circumstances). In addition, all products—supplements included—must declare any active ingredients in their product, which Nova Products reportedly did not do. "Consumers who use [Nova's products] would be unaware of the presence of the undeclared drug ingredients and placed at risk for their associated adverse events," FDA said.
FDA said the products were also improperly marketed for claims which are restricted to drug products under the Federal Food, Drug and Cosmetic Act (FD&C Act) because they are "intended to prevent, treat or cure disease conditions and/or affect the structure or function of the body." This caused them to be misbranded under the law, FDA said.
Refused Inspection Meets New FDA Authority
But perhaps the most interesting part of the letter is buried near its end, when FDA contends that the firm violated Section 704(a)(1)(B) of the FD&C Act when it "made refusals to permit inspection" of its facility.
As recounted by FDA: "Our investigator was refused required access to the complete inventory of all products previously sampled. The FDA regards this refusal as a serious violation because it hinders our investigators’ ability to thoroughly and completely evaluate your firm’s ability to market and distribute products that do not violate the FDCA."
The incident is a rare instance of FDA asserting authority it recently obtained under the Food and Drug Administration Safety and Innovation Act (FDASIA). As explained in the July 2013 guidance Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection, FDASIA gave FDA the authority to deem products misbranded if a firm obstructs FDA's ability to inspect—or fully inspect—a facility.
In the past, some firms have sought to refuse or delay entry of FDA inspectors into their facility, hoping the additional time could be used to either clean up a facility or expunge certain records. In September 2012, for example, FDA released a Warning Letter to a Chinese company that reportedly threw FDA inspectors out of the manufacturing facility after they began uncovering a host of serious deficiencies.
Under the new rules, any attempts to prevent FDA from accessing parts of a facility it has the legal right to access—including records—will cause the agency to deem its products adulterated, thereby revoking the company's ability to legally market the product until violations are corrected.
[For a full explanation of FDA's inspection authority under FDASIA, please see our explanation here.]
FDA says in its letter to Nova that the company's refusal to allow its inspectors to access records was regarded "as a serious violation because it hinders our investigators’ ability to thoroughly and completely evaluate your firm’s ability to market and distribute products that do not violate the FD&C Act."
The company has since voluntarily recalled all eight products cited in the Warning Letter, FDA noted.
Warning Letter to Nova